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Sidena 25, 50 & 100mg PIL *VAR 2* Lek 01-13_Sidena 25, 50 & 100mg 19/02/2013 12:11 Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sidena 25 mg, 50 mg & 100 mg Tablets
Sildenafil
Read all of this leaflet carefully
before you start taking this
medicine.
• Keep this leaflet. You may need
to read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been
prescribed for you.
Do not pass it on to others. It
may harm them, even if their
symptoms are the same as
yours.
• If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
In this leaflet:
1.What Sidena is and what it is used
for
2.Before you take Sidena
3.How to take Sidena
4.Possible side effects
5.How to store Sidena
6.Further information
1
What
Sidena is and what it is
used for
Sidena belongs to a group of
medicines called phosphodiesterase
type 5 (PDE5) inhibitors. It works by
helping to relax the blood vessels in
your penis, allowing blood to flow into
your penis when you get sexually
excited. Sidena will only help you to
get an erection if you are sexually
stimulated. You should not take
Sidena if you do not have erectile
dysfunction. You should not take
Sidena if you are a woman.
Sidena is a treatment for men with
erectile dysfunction, sometimes
known as impotence. This is when a
man cannot get, or keep a hard, erect
penis suitable for sexual activity.
2
Before
Do not take Sidena
– if you are taking medicines called
nitrates, as the combination may
cause a potentially dangerous
decrease in your blood pressure.
Tell your doctor if you are taking
any of these medicines which are
often given for relief of angina
pectoris (or “chest pain”). If you
are not certain, ask your doctor or
pharmacist.
– if you are using any of the drugs
known as nitric oxide donors such
as amyl nitrite (“poppers”), as the
combination may also lead to a
potentially dangerous decrease in
your blood pressure.
– if you are allergic (hypersensitive)
to sildenafil or any of the other
ingredients of Sidena
– if you have a severe heart or liver
problem
– if you have recently had a stroke or
a heart attack, or if you have low
blood pressure
– if you have certain rare inherited
eye diseases (such as retinitis
pigmentosa)
– if you have ever had loss of vision
because of non-arteritic anterior
ischaemic optic neuropathy
(NAION).
Take special care with Sidena
Tell your doctor
– if you have sickle cell anaemia (an
abnormality of red blood cells),
leukaemia (cancer of blood cells),
multiple myeloma (cancer of bone
marrow).
– if you have a deformity of your
penis or Peyronie’s Disease.
– if you have problems with your
heart. Your doctor should in that
case carefully check whether your
heart can take the additional strain
of having sex
– if you currently have a stomach
ulcer, or a bleeding disorder (such
as haemophilia)
– if you experience sudden decrease
or loss of vision, stop taking Sidena
and contact your doctor
immediately.
taken any other medicines, including
medicines obtained without
prescription.
Sidena tablets may interfere with
some medicines, especially those
used to treat chest pain. In the event
of a medical emergency, you should
tell any healthcare professional
treating your condition that you have
taken Sidena and when you did. Do
not take Sidena with other medicines
unless your doctor tells you that you
can.
You should not take Sidena if you are
taking medicines called nitrates, as
the combination of these products
may cause a potentially dangerous
decrease in your blood pressure.
Always tell your doctor or pharmacist
if you are taking any of these
medicines that are often used for the
relief of angina pectoris (or “chest
pain”).
You should not take Sidena if you are
using any of the drugs known as nitric
oxide donors such as amyl nitrite
(“poppers”) as the combination may
also lead to a potentially dangerous
decrease in your blood pressure.
If you are taking protease inhibitors,
such as for the treatment of HIV, your
doctor may start you on the lowest
dose (25 mg) of Sidena.
Some patients who take alphablocker
therapy for the treatment of
high blood pressure or prostate
problems may experience dizziness
or light-headedness, which may be
caused by low blood pressure upon
sitting or standing up quickly. Certain
patients have experienced these
symptoms when taking Sidena with
alpha-blockers. This is most likely to
occur within 4 hours after taking
Sidena. In order to reduce the
likelihood that these symptoms occur,
you should be on a regular daily dose
of your alpha-blocker before you start
Sidena. Your doctor may start you on
a lower dose (25 mg) of Sidena.
Taking Sidena with food and drink
Sidena can be taken with or without
food. However, you may find that
Sidena takes longer to start working if
you take it with a heavy meal.
Drinking alcohol can temporarily
impair your ability to get an erection.
To get the maximum benefit from your
medicine, you are advised not to drink
excessive amounts of alcohol before
taking Sidena.
Pregnancy and breast-feeding
Sidena is not indicated for use by
women.
Driving and using machines
Sidena can cause dizziness and can
affect vision. You should be aware of
how you react to Sidena before you
drive or use machinery.
3
How to take Sidena
Always take Sidena exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure. The usual starting dose
is 50 mg.
You should not take Sidena more
than once a day.
You should take Sidena about one
hour before you plan to have sex.
Swallow the tablet unchewed with a
glass of water.
Sidena 25 mg: The scoreline is only
to facilitate breaking for ease of
swallowing.
Dividing the tablets
Place the tablet on a hard, flat
surface with the scoreline facing
upwards. Press with your thumb on
the middle of the tablet and the tablet
breaks into equal halves.
you take Sidena
continued on the next page >>
You should not use Sidena with any
other treatment for erectile
dysfunction.
Special considerations for children
and adolescents
Sidena should not be given to
individuals under the age of 18.
Special considerations for patients
with kidney or liver problems
You should tell your doctor if you
have kidney or liver problems. Your
doctor may decide on a lower dose
for you.
Using other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
Sidena 50 mg:
The tablet can be divided into equal
quarters. You have to take at least
two quarters (corresponding to
25 mg) to reach the minimum
effective dose.
Dividing the tablets
Place the tablet on a hard, flat
surface with the scoreline facing
upwards. Press with your thumb on
the middle of the tablet and the tablet
breaks into equal quarters.
Sidena 100 mg:
The tablet can be divided into equal
quarters.

Sidena 25, 50 & 100mg PIL *VAR 2* Lek 01-13_Sidena 25, 50 & 100mg 19/02/2013 12:11 Page 2
Dividing the tablets
Place the tablet on a hard, flat 5
How to store Sidena
surface with the deeper scoreline
facing upwards. Press with your Keep out of the reach and sight of
thumb on the middle of the tablet and children.
the tablet breaks into equal quarters.
This medicinal product does not
If you have the impression that the require any special storage
effect of Sidena is too strong or too conditions.
weak, talk to your doctor or
pharmacist.
Do not use Sidena after the expiry
date which is stated on the carton
Sidena will only help you to get an and label. The expiry date refers to
erection if you are sexually
the last day of that month.
stimulated. The amount of time
Sidena takes to work varies from Medicines should not be disposed of
person to person, but it normally via wastewater or household waste.
takes between half an hour and one Ask your pharmacist how to dispose
hour. You may find that Sidena takes of medicines no longer required.
longer to work if you take it with a These measures will help to protect
heavy meal.
the environment.
6
If Sidena does not help you to get an
Further information
erection, or if your erection does not
last long enough for you to complete What Sidena contains
sexual intercourse you should tell your The active substance is sildenafil.
doctor.
Each tablet contains 25 mg/50 mg/
If you take more Sidena than you 100 mg of sildenafil (as the citrate
should
salt).
You may experience an increase in
side effects and their severity. Doses The other ingredients are: calcium
above 100 mg do not increase the hydrogen phosphate anhydrous,
efficacy.
microcrystalline cellulose, copovidone,
croscarmellose sodium, magnesium
You should not take more tablets stearate, saccharin sodium, indigo
than your doctor tells you to. carmine aluminium lake (E 132).
Contact your doctor if you take more What Sidena looks like and
tablets than you should.
contents of the pack
Sidena 25 mg Tablets
If you have any further questions on Sidena 25 mg Tablets are light blue
the use of this medicine, ask your round slightly dotted tablets, with
doctor or pharmacist.
breaking notch on one side and
4
embossment “25” on the other side.
Possible side effects
Like all medicines, Sidena can cause
side effects although not everybody
gets them. The side effects reported
in association with the use of Sidena
are usually mild to moderate and of a
short duration.
If you have chest pains during or after
intercourse:
– Get in a semi-sitting position and try
to relax.
– Do not use nitrates to treat your
chest pain.
– Contact your doctor immediately.
All medicines including Sidena can
cause allergic reactions. You should
contact your doctor immediately if you
experience any of the following
symptoms after taking Sidena:
sudden wheeziness, difficulty in
breathing or dizziness, swelling of the
eyelids, face, lips or throat.
Prolonged and sometimes painful
erections have been reported after
taking Sidena. If you have an erection
which lasts for more than 4 hours,
you should contact a doctor
immediately.
If you experience a sudden decrease
or loss of vision, stop taking Sidena
and contact your doctor immediately.
A very common side effect (likely to
occur in more than 1 in 10 patients) is
headache.
Common side effects (likely to occur
in 1 to 10 patients in 100) include:
facial flushing, indigestion, effects on
vision (including colour tinge to vision,
light sensitivity, blurred vision or
reduced sharpness of vision) stuffy
nose and dizziness.
Sidena 50 mg Tablets
Sidena 50 mg Tablets are light blue
round slightly dotted tablets, with
cross breaking notch on one side and
embossment “50” on the other side.
Sidena 100 mg Tablets
Sidena 100 mg Tablets are light blue
round slightly dotted tablets, with
cross breaking notch on both sides
and embossment “100” on one side.
Sidena is available in blister packs
with 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 or
28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:
Rowex Ltd., Bantry, Co. Cork, Ireland.
Manufacturers:
Lek Pharmaceuticals d.d., Verovškova
57, 1526 Ljubljana, Slovenia.
Salutas Pharma GmbH, Otto-von-
Guericke Allee 1, 39179 Barleben,
Germany.
Salutas Pharma GmbH, Dieselstr. 5,
70839 Gerlingen, Germany.
S.C. Sandoz S.R.L., 7A Livezeni
Street, 540472 Targu Mures, Jud.
Mures, Romania.
Lek S.A., ul. Domaniewska 50 C, 02-
672 Warszawa, Poland.
This medicinal product is
authorised in the Member States of
the EEA under following names:
The Netherlands Sidena 25 mg,
tabletten
Sidena 50 mg,
tabletten
Sidena 100 mg,
tabletten
Uncommon side effects (likely to
occur in 1 to 10 patients in 1000)
include: vomiting, skin rash, bleeding
at the back of the eye, eye irritation,
bloodshot eyes/red eyes, eye pain,
double vision, abnormal sensation in
the eye, irregular or rapid heartbeat,
muscle pain, feeling sleepy, reduced
sense of touch, vertigo, ringing in the
ears, nausea, dry mouth, chest pain
and feeling tired.
Rare side effects (likely to occur in 1
to 10 patients in 10000) include: high
blood pressure, low blood pressure,
fainting, stroke, nosebleed and
sudden decrease or loss of hearing.
Ireland
Sidena 25 mg
Tablets
Sidena 50 mg
Tablets
Sidena 100 mg
Tablets
This leaflet was last approved in
09/2010.
I.M. L/334a+b+c 01-13
46103576
Additional side effects reported from
post-marketing experience include:
pounding heartbeat, chest pain,
sudden death, heart attack or
temporary decreased blood flow to
parts of the brain. Most, but not all, of
these men had heart problems before
taking this medicine. It is not possible
to determine whether these events
were directly related to Sidena. Cases
of convulsions or seizures and
serious skin reactions characterised
by rash, blisters, peeling skin and
pain which require immediate medical
attention have also been reported.
If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet please tell your
doctor.